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Lt0500 e bio-tenodesis screw system


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Lt0500 e bio-tenodesis screw system

  1. 1. Bio-Tenodesis Screw Fixation Bio-Tenodesis™ Screw Fixation in Tendon Enhanced Ankle Ligament Reconstruction Surgical Technique Kevin O’Shea, M.D. with contributions from Thomas Clanton, M.D., and William McGarvey, M.D.
  2. 2. Bio-Tenodesis Screw Fixation in Tendon Enhanced Ankle Ligament Reconstuction Surgical Technique This surgical technique describes an augmented ankle reconstruction using a free tendon graft and rigid interference screw fixation using the Bio-Tenodesis System. The goal of this technique is to achieve an anatomic reconstruction of the anterior talofibular and calcaneofibular ligaments with simple tensioning and rigid fixation of the graft. Rigid fixation allows earlier postoperative motion. A smaller incision is needed and less surgical exposure is required. In addition, the peroneal tendons are not disturbed. Tissue augmentation in ankle ligament reconstruction is usually reserved for patients with ligamentous laxity or surgical revisions. Common to these techniques is the need for wide surgical exposures, lack of rigid fixation of the graft and the recommended postoperative immobilization. Revision ankle ligament reconstruction is an option for the patient with recurrent instability and is usually performed with tissue augmentation. Many of these techniques (Evans/Chrisman-Snook) are nonanatomic. Anatomic procedures include those described by Drs. Elmslie and Colville. Some of these techniques use the peroneus brevis tendon to augment ligamentous tissue. Dr. Coughlin described an anatomic reconstruction using a free semitendinosus graft and stressed the importance of preserving peroneal tendon function in patients with recurrent ankle instability. The method of graft fixation is similar in all of these techniques which involves passing the tendon graft through bone tunnels and suturing it back on itself. This type of fixation is quite variable and is based on the size of the bone bridge created, the quality of bone and the holding strength of the suture in the tendon. Graft Harvesting & Preparation Harvest the semitendinosus tendon from the ipsilateral knee. An allograft soft tissue tendon may also be used. The graft length should be 14 cm for most patients. It is suggested that a locking whipstitch, using 2-0 or #2 FiberWire® be created at the end of the graft to be placed into the talar attachment site. The whipstitch should extend no more than 15 mm from the tip of the tendon, as this resembles the length of the 4.75 & 5.5 mm x 15 mm Bio-Tenodesis Screws suggested for this procedure. Using the sizing holes on the Bio-Tenodesis Driver’s thumbpad, take an accurate diameter measurement of the tendon. Selection of the appropriate Bio-Tenodesis Screw should be based on the diameter of the tendon from the tip of the tendon to approximately 15 mm along the graft at both ends. Option B 1 2 Option A An arthrotomy is made at the talofibular joint and After anatomic attachment sites are determined, pilot is carried around the distal end of the fibula to the holes are drilled with a 2.4 mm guide pin in the talar neck peroneal sheath. This sheath is opened and the and calcaneus. Two options are described for reaming the peroneal tendons are retracted posteriorly. The capsule fibular sockets. and periosteum over the distal fibula is elevated, Drill Technique Option A: A 5 mm cannulated reamer exposing the previous insertion of the calcaneofibular from the anterior and distal fibula at the insertion point and anterior talofibular ligaments. of the anterior talofibular and calcaneal fibular ligaments. These tunnels are connected using a curved curette. Drill Technique Option B: The fibular socket (ATFL arm) should start anterior to posterior, angling slightly proximal and exiting the posterior fibula. The CFL arm is drilled from the anatomic attachment site of the CFL on the tip of the fibula to the posterior fibula. This approach will increase the bone bridge between the ATFL arm and CFL arm of this construct.
  3. 3. Option B 3 4 Option A A 5.5 mm diameter x 17 mm long tunnel is drilled in Creation of FiberWire Suture Loop the talus and a 5 mm tunnel is created in the fibula for Prior to placement of the talar screw or calcaneal screw, passage of the graft. use the nitinol wire and #2 FiberWire to create a suture loop at the tip of the Bio-Tenodesis Driver. Snare the Note on creation of bone tunnels: tip of the whipstitched tendon 2 mm from the end of • Proper screw and pilot hole diameter depends the graft. Place tension on the sutures exiting the back on the exact diameter of the tendon graft of the Tear Drop Handle and wrap them once around • Bone tunnel diameter should be .5 mm to the o-ring inside the cleat. It is important to maintain 1 mm larger than the size of the tendon maximum tension between the driver tip and the tendon (ex. 4.5 mm graft requires 5-5.5 mm diameter hole) during initial placement of the tendon in the tunnel. 5a 5b 5 6 Place the driver tip with tendon into the bone socket. It is To pass the ATFL arm of the graft through the important that the tip of the driver with tendon attached be fibula, insert the nonlooped end of the Nitinol placed in the tunnel until the proximal screw threads are in Suture Passing Wire through the anterior fibular contact with the anterior cortex. Prior to turning the Tear drill hole and distally through the tunnel exiting the Drop Handle, make sure the tendon is seated properly in hole on the bottom of the fibula. With the Nitinol the tunnel (Fig 5a). Turn the blue handle clockwise while loop exposed, insert both tails of the traction stitch holding the metal thumbpad stationary. The screw is seated one inch from the tip. Pull the Nitinol loop through properly when it is flush with the cortical bone. Remove the fibular tunnel, passing the graft from proximal the driver and tie the suture tails over the top of the screw. to distal. The tendon graft is now ready for proper Cut the remaining suture (Fig 5b). anatomic tensioning and calcaneal screw placement.
  4. 4. Peroneal Tendons Point A 17 mm 7 8 Point B Option B Fibular Drilling Technique Tension the CFL arm with neutral ankle flexion and Pass the tendon graft anterior to posterior and place a slight heel eversion and mark a blue line across the right angle clamp at the posterior exit point, tensioning tendon where the graft should enter calcaneal bone the ATFL arm of the construct with the ankle in slight tunnel (Point A). Measure 17 mm down (2 mm more eversion. Place sutures into the periosteum on both sides than length of 5.5 mm x 15 mm screw) on the remaining of the ATFL arm of this construct on the posterior fibula. tendon graft and place another blue mark. Whipstitch Use the Nitinol loop to aid passage of the remaining the portion of the tendon between the two blue lines portion of the graft through the distal fibular drill hole, and remove any excess tendon (Point B). Refer to Step 4 positioning the graft underneath the peroneal tendons. for placement of calcaneal screw. Place the heel in slight eversion and the ankle in a neutral position prior to screw insertion. To insert the screw hold thumbpad and turn the blue Tear Drop Handle. Insert the screw until it is flush with the lateral cortex. 9a Option B 9 10 Option A Alternative Fixation Method in Calcaneus The construct is complete, using fibular drilling Using a 2.4 mm beath pin (w/eyelet), drill a pilot hole techniques. from the insertion point (CFL) posteromedially, exiting the medial cortex of the calcaneus. Overdrill the pilot hole with 5.5 mm reamer to a depth of 17 mm. The suture on the end of the tendon is passed through the tunnel with the aid of the beath pin. This suture is tensioned, pulling the graft into the tunnel. The driver with screw attached is placed over the graft and inserted while tension is applied to the traction suture. The remaining traction suture is 6.25 mm 7 mm 7 mm 8 mm 8 mm PEEK 8 mm 9 mm cut. Reference (9a) for close-up of the complete construct using this alternative fixation method. 3 mm 4 mm 4.75 mm 4.75 mm 5.5 mm 5.5 mm 5.5 mm 5.5 mm titanium titanium PEEK PEEK
  5. 5. Ordering Information Bio-Tenodesis Screw System Implants, sterile, single use: Bio-Tenodesis Screw w/handled inserter, 3 mm x 8 mm AR-1530B Bio-Tenodesis Screw, 4 mm x 10 mm AR-1540B Bio-Tenodesis Screw, 4.75 mm x 15 mm AR-1547B Tenodesis Screw, titanium, 4.75 mm x 15 mm AR-1350-475 PEEK Tenodesis Screw, 5.5 mm x 15 mm AR-1555PS PEEK Tenodesis Screw, 5.5 mm x 8 mm AR-1655PS PEEK Tenodesis Screw, 8 mm x 12 mm AR-1680PS Tenodesis Screw, titanium, 5.5 mm x 15 mm AR-1350-55 Bio-Tenodesis Screw, 5.5 mm x 15 mm AR-1555B Bio-Tenodesis Screw, 6.25 mm x 15 mm AR-1562B Bio-Tenodesis Screw, 7 mm x 23 mm AR-1570B Bio-Tenodesis Screw, 8 mm x 23 mm AR-1580B Bio-Tenodesis Screw, 9 mm x 23 mm AR-1590B Bio-Tenodesis Screw, 7 mm x 10 mm AR-1670B Bio-Tenodesis Screw, 8 mm x 12 mm AR-1680B Disposable Tenodesis Driver w/5.5 mm Screw and #2 FiberWire AR-1555DS includes: driver, 5.5 mm screw, preloaded #2 FiberWire loop Bio-Tenodesis Master Instrument Set (AR-1675S) includes: Tear Drop Handle w/Suture Cleat AR-2001BT Cannulated Drill, 4 mm AR-1204L Cannulated Drill, 4.5 mm AR-1204.5L Cannulated Headed Reamers, 5 mm - 10 mm AR-1405 - 1410 Driver for 10 mm long Bio-Tenodesis Screw AR-1540DB Driver for 12 mm long Bio-Tenodesis Screw AR-1670DB Driver for 15 mm long Bio-Tenodesis Screw AR-1350D Driver for 23 mm long Bio-Tenodesis Screw AR-1570DB Bio-Tenodesis Screw Instrumentation Case AR-1675C Optional Disposable Accessories: Bio-Tenodesis Disposables Kit AR-1676DS includes: Short Guide Pin, Suture Passing Wire, Skin Marking Pen, ruler, #2 FiberLoop w/Straight Needle, two #2 FiberWire, two 2-0 FiberWire Small Diameter Bio-Tenodesis Disposables Kit AR-1677DS includes: Short Guide Pin, Suture Passing Wire, Skin Marking Pen, ruler, 0 FiberWire, 0 TigerWire, 2-0 FiberWire, 2-0 FiberLoop Bio-Tenodesis Disposables Kit for 3 mm x 8 mm screw AR-1530DS includes: Suture Passing Wire, two Drills, two 2-0 FiberWire #2 FiberSnare, #2 FiberWire, 26 inches (green) stiffened w/closed loop, 12 inches AR-7209SN #2 FiberLoop w/Straight Needle AR-7234 Cannulated Drill Bits (accepts 2.4 mm K-wires) 2.5 mm cannulation, for use with AR-1676DS: Cannulated Drill Bit, 5 mm AR-1676C-50 Cannulated Drill Bit, 5.5 mm AR-1676C-55 Cannulated Drill Bit, 6 mm AR-1676C-60 Cannulated Drill Bit, 6.5 mm AR-1676C-65 Cannulated Drill Bits (accepts 1.57 mm K-wires) 1.7 mm cannulation, for use with AR-1677DS: Cannulated Drill Bit, 4 mm AR-1677C-40 Cannulated Drill Bit, 4.5 mm AR-1677C-45 Cannulated Drill Bit, 5 mm AR-1677C-50 Cannulated Drill Bit, 5.5 mm AR-1677C-55 Optional Accessories: Bio-Tenodesis Tap, 4 mm x 10 mm AR-1540T Bio-Tenodesis Tap, 4.75 mm x 15 mm AR-1547T Bio-Tenodesis Tap, 5.5 mm x 15 mm AR-1555T Bio-Tenodesis Tap, 6.25 mm x 15 mm AR-1562T Bio-Tenodesis Tap, 7 mm x 23 mm AR-1570T Bio-Tenodesis Tap, 7 mm x 10 mm AR-1670T Bio-Tenodesis Tap, 8 mm x 12 mm AR-1680T Drill Pin Tip Headed Reamer, 7 mm AR-1407DP
  6. 6. This description of technique is provided as an educational tool and clinical aid to assist properly licensed medical professionals in the usage of specific Arthrex products. As part of this professional usage, the medical professional must use their professional judgment in making any final determinations in product usage and technique. In doing so, the medical professional should rely on their own training and experience and should conduct a thorough review of pertinent medical literature and the product’s directions for use. © Copyright Arthrex Inc., 2008. All rights reserved. LT0500E U.S. PATENT NOS. 6,544,281 and 6,716,234